Optimizing Response in Psychosis Study (ORP)

This study has suspended participant recruitment.
(Recruitment for the study was limited. Further recruitment is suspended during evaluation of potential study design changes.)
Sponsor:
Collaborators:
The Zucker Hillside Hospital
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Delbert Robinson, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00314327
First received: April 11, 2006
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

The purpose of this project is to evaluate the efficacy of long-acting risperidone for patients with first episode schizophrenia spectrum who did not improve sufficiently with the first antipsychotic medication they tried during their initial treatment trial.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Psychotic Disorder Not Otherwise Specified
Drug: long-acting injectable risperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimizing Response in Psychosis Study

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • treatment response based upon BPRS and CGI ratings [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • side effects based upon rating instruments and lab tests [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • patient acceptance of injections [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • negative symptoms [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2006
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: long-acting injectable risperidone
    One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.
    Other Name: Risperdal (oral) & Risperdal Consta
Detailed Description:

The goal of the proposed pilot study is to investigate the feasibility and efficacy of the long-acting injectable form of the second generation antipsychotic, risperidone, for the treatment of first episode patients who fail to respond to 12 weeks of treatment with an oral antipsychotic. The rationale for using this long-acting medication is that it eliminates covert non-adherence, which may be a factor in poor response. In addition, pharmacokinetic and pharmacodynamic differences between injectable and oral formulations may result in differences in treatment response favoring the injectable form. Subjects who have not responded sufficiently to treatment with an antipsychotic will be approached for the proposed long-acting risperidone trial. Risperidone treatment will be open label with titration based upon individual response (within FDA approved dose ranges). Treatment will begin with a phase of supplementation with oral risperidone. Subjects will stop their previous antipsychotic, start 2 mg of oral risperidone per day for one day and then increase the dose to 4 mg per day. Subjects who tolerate one week of oral risperidone will then begin injections of 25 mg long-acting risperidone every 2 weeks for a total of 12 weeks. If clinically indicated, the dose may be increased up to a maximum of 50 mg as per FDA guidelines.

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current DSM-IV-defined diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, or psychotic disorder NOS as assessed using the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P) (First et al, 1998)
  • Is in the first episode of illness. First episode is defined as having had 6 months or less of lifetime treatment with an antipsychotic.
  • Has not responded sufficiently to treatment with an antipsychotic. Lack of response is defined as a rating at study entry of 4 (moderate) or more on at least one of the following BPRS-A items: conceptual disorganization, grandiosity, hallucinatory behavior, unusual thought content.
  • Continuous antipsychotic treatment at the time of study entry of a minimum of 12 weeks with the same antipsychotic agent.
  • Antipsychotic dosing at some point during the 12 weeks must have reached a sufficient dose for antipsychotic response (e.g. patients who received only low dose quetiapine for insomnia or anxiety would not qualify). Sufficient dose for second generation antipsychotics is defined as a minimum dose of risperidone 3 mg/day, olanzapine 10 mg/day, quetiapine 500 mg/day, ziprasidone 100 mg/day or aripiprazole 15 mg/day. Sufficient dose for first generation antipsychotics is defined as 3 mg/day of haloperidol or its equivalent for other first generation agents.
  • Aged 15 to 40.
  • If age 18 or older, competent and willing to sign informed consent.
  • If under age 18, parent or guardian consent and subject assent.
  • For women, a negative urine pregnancy test and agreement to use a medically accepted method of birth control.

Exclusion criteria:

  • Meets DSM-IV criteria for a current substance-induced psychotic disorder, a psychotic disorder due to a general medical condition, delusional disorder, brief psychotic disorder, shared psychotic disorder, or a mood disorder (major depression or bipolar) with psychotic features.
  • Persistence of psychotic symptoms due to nonadherence to antipsychotic medication.
  • Medical contraindications to treatment with long-acting injectable risperidone.
  • Serious neurological or endocrine disorder or medical condition /treatment known to affect the brain.
  • A medical condition requiring medication with psychotropic effects.
  • Clinical assessment that trial participation is contraindicated due to risk for homicidal or suicidal behavior.
  • A diagnosis of diabetes (fasting glucose > 126 mg/dl).
  • Requires with antidepressant or mood stabilizing medication.
  • Previous treatment with a long acting formulation of an antipsychotic
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314327

Locations
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
North Shore Long Island Jewish Health System
The Zucker Hillside Hospital
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Delbert G Robinson, M.D. The North Shore-Long Island Jewish Health System
  More Information

Additional Information:
No publications provided

Responsible Party: Delbert Robinson, MD, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00314327     History of Changes
Other Study ID Numbers: 05.04.161
Study First Received: April 11, 2006
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
first episode
schizophrenia
risperidone

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 26, 2014